IMPact of AerobiC Exercise in Addition to Nutritional Treatment on Quality of Life After Pancreatectomy

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Tumors; Diabetes; Malabsorption

• Registration Number: NCT06858631
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The goal of this interventional study is to assess the impact of a 6-month unsupervised aerobic exercise program on the quality of life of patients undergoing partial or total pancreatectomy. The main question it aims to answer is:

Does an aerobic exercise program improve physical functioning and overall quality of life in post-pancreatectomy patients?

Eligible participants will be assigned to either an exercise group or a control group. Quality of life will be evaluated using standardized scoring scales, with a focus on physical functioning. Secondary outcomes include changes in metabolic parameters (glycemia, HbA1c, lipid profile), BMI, and overall survival.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Signed informed consent
• Male or female patients who have undergone partial or total pancreatectomy
• Age ≥18 and ≤80 years
• Ability to understand and complete questionnaires and willingness to participate in periodic assessments
• No symptoms suggestive of cardiovascular issues (e.g., angina, dyspnea, palpitations, syncope)
• No evidence of ischemic heart disease, cardiomyopathy, valvular heart disease, myocarditis, autoimmune diseases, infections, or fractures that would contraindicate moderate-intensity aerobic activity

Exclusion Criteria

• Age >80 or <18 years
• Cardiovascular, musculoskeletal, rheumatologic, or neurocognitive disorders contraindicating aerobic exercise
• 10-year cardiovascular risk >20% without cardiological/sports medicine evaluation
• Diagnosis of unresectable tumor
• Presence of metastases
• Pregnancy or breastfeeding
• Ongoing chemotherapy and/or radiotherapy
• BMI ≥30
• BMI ≤18.5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life	12 months	Identify changes in the quality-of-life score from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (v3). The EORTC QLQ-C30 (v3) evaluates health status through nine multi-item scales: Five functional scales (physical, role, cognitive, emotional, social); three symptom scales (fatigue, pain, nausea/vomiting); one global health status scale. Additionally, six single-item scales assess symptoms commonly associated with neoplastic disease and its treatment (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

Secondary Outcome Measures

Name	Time	Method
Detect changes in physical symptomps with the pancreas-specific PAN26 questionnaire.	12 months	Assess possible changes in physical symptomps with the pancreas-specific PAN26 questionnaire. The PAN26 questionnaire consists of 26 four-level items, producing seven multi-item scale scores (each composed of two to four items) and nine single-item scores.
Assessing changes in muscle power between subjects ongoing nutritional plan versus subjects ongoing nutritional plan and physical exercise	12 months	The subjects will be using their dominant hand, applies as much grip pressure as possible on the dynamometer. The assistant will record the maximum reading (kg). The subjects will repeat the test 3 times and the highest recorded value will be recorded to assess the subject's performance.
Detect changes in body mass index during the follow-up.	12 months	At each follow-up visit, height (m) and weight (kg) will be recorded. BMI will then be measured as kg/m².

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, RM, Italy